Intrauterine System with Open Frame and Composite Drug Deposit
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Solution Overview
Problem
Existing intrauterine systems face challenges in manufacturing a device that is strong enough for insertion and removal, yet small enough to prevent injury, with a predictable release rate of biologically active compounds, and a simple construction that can be easily adapted for various treatments.
Innovation Solution
An intrauterine system with a frame having an open structure and a deposit of a therapeutically effective dose of a biologically active compound, where the frame and deposit interact to form a composite mechanical structure, allowing for greater mechanical strength and flexibility, and a rate of release primarily determined by the structure and environment, enabling easy insertion and removal.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Quantity of substance
If the device is made larger to store sufficient dose of biologically active compound, then the drug storage capacity is improved, but the device causes injury or pain during insertion through the cervix
Solution Approach 1:
The device is divided into two separate components: a flexible frame that can be inserted through the cervix and a deposit containing the biologically active compound. The deposit is inserted through the frame after insertion, allowing the frame to remain small for safe insertion while the deposit provides sufficient drug storage capacity.
Solution Approach 2:
The deposit is inserted through the interior space of the frame, creating a nested structure where the deposit resides within the frame's interior space. This allows the frame to maintain a small insertion profile while accommodating a sufficiently large deposit for therapeutic dosing.
2Strength
If the frame structure is made stronger to endure insertion and removal forces, then the mechanical strength is improved, but the device complexity increases
Solution Approach 1:
The frame is constructed from a composite material comprising a mixture of polymers and plasticizer, providing the necessary mechanical strength and flexibility without requiring complex structural designs. The flexible nature of this composite material allows the frame to endure insertion and removal forces while maintaining structural integrity.
Solution Approach 2:
The frame is designed to be flexible rather than rigid, allowing it to dynamically adapt to the forces of insertion and removal. The flexible frame can deform during insertion through the cervix and during removal, then return to its original shape, providing strength through elasticity rather than structural complexity.
3Manufacturing precision
If a rate controlling membrane is used to control drug release, then the release rate control is improved, but the manufacturing complexity increases due to the need for integrity of the membrane
Solution Approach 1:
The deposit itself is designed with local quality variations to control drug release. Different regions of the deposit can have different compositions or structures that control the release rate, eliminating the need for a separate rate-controlling membrane and its associated manufacturing complexity.
Solution Approach 2:
The rate-controlling function is extracted from a separate membrane component and integrated directly into the deposit structure. This eliminates the need for a distinct rate-controlling membrane layer, simplifying the manufacturing process while maintaining precise release rate control through the deposit's inherent properties.
4Ease of operation
If the frame is made smaller to facilitate insertion, then the ease of insertion is improved, but the mechanical strength decreases
Solution Approach 1:
The use of composite materials with plasticizers provides the frame with high flexibility and elasticity, allowing it to be made small for easy insertion while maintaining the mechanical strength needed to endure insertion and removal forces. The composite material's viscoelastic properties allow the frame to deform and recover, providing strength without increasing size.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The system achieves improved mechanical strength, ease of insertion, and predictable release rates, ensuring effective treatment of conditions like dysfunctional uterine bleeding, menorrhagia, and endometriosis while minimizing device development and complexity.
Implementation Method 1
the rate controlling effect on the steady state release of the compound to the uterus may be primarily determined by the structure of the deposit itself
Data Source
AI summary
An intrauterine system is disclosed for use in the treatment of dysfunctional uterine bleeding; menorraghia; dysmenorrhoea; endometriosis; uterine fibroids; climacteric complaints; osteoporosis; and urogenital atrophy. The system is formed by a frame defining an interior space for receipt of a deposit of a therapeutically effective dose of a biologically active compound. The frame has an open structure allowing access to a substantial part of an outer surface of the deposit, and the deposit has a rate controlling structure that controls a rate of release of the compound within the uterus. One or more retention elements are provided on the frame for retaining the frame within the uterus of a female mammal.